Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1936-2025 — SmartPath to dStream for 1.5T¿; Product Number: 782146;

U.S. FDA — Device Enforcement · United States · 2025-05-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1936-2025
Date of alert
2025-05-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America
Product category
device
Product type
Devices
Reported risk: identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.